1002-047 Hyperlipidemia Study
Research type
Research Study
Full title
A LONG-TERM, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY OF BEMPEDOIC ACID (ETC-1002) IN PATIENTS WITH HYPERLIPIDEMIA AT HIGH CARDIOVASCULAR RISK NOT ADEQUATELY CONTROLLED BY THEIR LIPID-MODIFYING THERAPYe
IRAS ID
219602
Contact name
Paul Ivan
Contact email
Sponsor organisation
Esperion Therapeutics Inc
Eudract number
2016-003486-26
Duration of Study in the UK
1 years, 4 months, 17 days
Research summary
This is a Phase 3, long-term, randomised, double-blind, placebo-controlled, multi-centre study evaluating the efficacy of bempedoic acid (ETC-1002) in high cardiovascular risk patients with hyperlipidaemia (patients with underlying heterozygous familial hypercholesterolemia [HeFH] and/or atherosclerotic cardiovascular diseases [ASCVD]) who are not adequately treated with their maximally tolerated lipid-modifying therapy.
The main purpose of the study is to see how well the study drug works to reduce the amount of low density lipoprotein cholesterol (LDL-C) in the body in patients who are at high risk for cardiovascular (CV) disease and whose hyperlipidaemia (high levels of lipids – fats, cholesterol and triglycerides – in the body) is not well enough controlled with lipid-lowering therapy. The study will compare the study drug to a placebo. The study will also look at how safe the study drug is (for example, what side effects it might cause).
Approximately 750 patients (adult male and female) at about 125 study centres in North America and Europe will take part in this study. All patients will be treated for 56 weeks.
The participants will be assigned to one of the following study groups:
• Study drug – one 180 mg tablet once a day
• Placebo - one tablet once a day (A placebo looks the same as the study drug but contains no actual medication)
Bempedoic acid has been evaluated in 19 completed clinical studies, with over 2300 subjects and patients who received at least 1 dose of study medication, with more than 1500 of these receiving bempedoic acid doses ranging from 2.5 up to 240 mg/day. The 2300 number includes more than 800 patients in the Phase 3 safety population from an on going double-blind study. All multiple-dose studies have demonstrated consistent, clinically meaningful LDL-C lowering with bempedoic acid treatment and have shown a positive safety profile.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0038
Date of REC Opinion
17 Mar 2017
REC opinion
Further Information Favourable Opinion